MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number ENVPRO-16-US

Device Problem Failure to Advance (2524)

Patient Problems Intimal Dissection (1333); Death (1802); Hemorrhage/Bleeding (1888); Renal Failure (2041); Vascular Dissection (3160)

Event Date 10/14/2020

Event Type  Death  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve via the left transfemoral approach, a 12, 16 and 18 fr dilator were advanced over a non-medtronic super stiff guidewire.A 18 fr medtronic introducer sheath was advanced.The native valve was crossed and then a pigtail wire was placed into the left ventricle.A double curve non-medtronic guidewire was placed into the left ventricle and the introducer sheath was exchanged for this 34 millimeter (mm) delivery catheter system (dcs).The dcs was unable to advance past the external iliac artery; which was reported to be small and calcified.A second 16 fr dcs was attempted but also was unable to advance.A 20 fr non-medtronic external sheath was also attempted and again, was unable to be advanced.The external sheath was pulled back and contrast was shot which revealed a dissection in the external iliac artery.Two 7 mm peripheral stents were implanted.7 mm, 8mm and 9 mm peripheral balloons were also utilized in an attempt to occlude the bleeding.These measures were unsuccessful, therefore a surgical repair of the left external iliac was performed.It was reported that per the physician, it was unknown which sheath or dcs originally caused the dissection.No additional adverse patient effects were reported. .

Manufacturer Narrative

Additional information was received that a total of four non-medtronic peripheral stents were placed prior to the vascular surgery.The patient was reported to be stable following surgery but subsequently died later in the week.The cause of death was not received.It is unknown whether an autopsy was performed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that the patient died one day following the valve implant.Updated: b2 (date of death), b5 (event description).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Additional information was received that reported that the cause of death was renal and multi organ failure following the surgical repair of the external iliac artery, likely due to the extensive bleeding that ensued.It was reported that per the physician, the death was related to the dissection and the valve implant procedure.Patient anatomy contributed to the dissection and death.An autopsy was not performed.Updated: g1, h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received with an unknown valve loaded in the dcs capsule.On attempted retraction of the capsule via the rotation of the deployment knob, the valve deployed as expected.The handle was intact.The dcs was received with the capsule fully closed.The deployment knob retracted and advanced the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism was intact.Delamination was observed over the nitinol reinforcing frame along the distal-section and along the mid-section to the proximal end of the capsule.The inner member shaft and spindle hub were intact with no evidence of damage.The dcs was returned with the end cap / screw gear snap fit connected.Conclusion: not yet available, evaluation of the product is in progress.Updated data: d8, d9, g1, h6 annex e, annex f, method, result, and conclusion codes medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Difficulties advancing the delivery catheter system (dcs) through patient anatomy is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuousity, etc.).In this case, it was noted that the external iliac artery was small and calcified.This indicates that the most likely cause of the advancement difficulties was calcified patient anatomy.There is no information to suggest a device quality deficiency that may have caused or contributed to this event, but a conclusive root cause cannot be determined at this time and a relationship to the dcs cannot be established.The dcs was returned to medtronic for analysis.Delamination was observed over the nitinol reinforcing frame along the distal section to the proximal end of the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.No procedural images were received for review to establish a root cause of the reported advancement difficulties.A 20 french non-medtronic external sheath was also attempted and again was unable to be advanced.The external sheath was pulled back and contrast was shot which revealed a dissection in the external iliac artery.Vascular injuries, such as dissection, are known potential adverse patient effects per the device instructions for use (ifu) and can occur during any percutaneous intervention.These events are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Based on the limited information available, an assignable root cause of the dissection cannot be confirmed and the relationship to the dcs could not be established.7 millimeter (mm), 8mm and 9 mm peripheral balloons were also utilized in an attempt to occlude the bleeding.However, the patient died one day following the valve implant.It was reported that the cause of death was renal and multi organ failure following the surgical repair of the external iliac artery, likely due to the extensive bleeding that ensued.It was reported that per the physician, the death was related to the dissection and the valve implant procedure.Patient anatomy contributed to the dissection and death.An autopsy was not performed.The exact cause of death is unknown but per the physician the dissection and death were related to the procedure.With the limited information available, a conclusive assessment of the relationship between the death and the device could not be reached.There is no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to this event.Updated: h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENVEO PRO DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10712488
• MDR Text Key: 212321324
• Report Number: 2025587-2020-03183
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169987210
• UDI-Public: 00643169987210
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: ENVPRO-16-US
• Device Catalogue Number: ENVPRO-16-US
• Device Lot Number: 0009839739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 77